Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction - Full Text View

Sponsor:	Bayer
Collaborator:	GlaxoSmithKline
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00662441

Purpose

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	Open-Label, Multi-Centre, Study of Levitra 10 mg Once a Day in Males With Erectile Dysfunction Was Carried Out in Four Centres Namely Lagos, Port Harcourt, Enuge and Maiduguri at Their University Teaching Hospitals

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

International Index of Erectile Function- Erectile Function domain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global Assessment Questionnaire (GAQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	102
Study Start Date:	September 2003
Study Completion Date:	June 2004

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) 10mg taken 1 hours before sexual intercourse

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men >/= 18 years of age
Erectile Dysfunction

Exclusion Criteria:

History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
Nitrate therapy
Other exclusion criteria apply according to the Summary of Product Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662441

Sponsors and Collaborators

Bayer

GlaxoSmithKline

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	100578
Study First Received:	April 16, 2008
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00662441 History of Changes
Health Authority:	Nigeria: The National Agency for Food and Drug Administration and Control

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010